OR WAIT null SECS
June 13, 2012
Are pharmaceutical manufacturers really serious about ensuring the quality of their medicines? And do they recognize that cutting corners on controls and quality management can be tremendously costly in the long run?
April 02, 2012
Understanding the differences between convenience, target, and self-selected samples.
The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.
The authors detail the possible consequences of noncompliance and a lack of quality control.
March 08, 2012
CML - Quality Assurance
February 02, 2012
Where is the variability coming from and what have we done to minimize it?
December 02, 2011
Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.
October 02, 2011
Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.
September 21, 2011
Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.
September 02, 2011
A summary of the latest steering committee and expert working groups' meeting.